FDA 510(k)

FloPatch FP120

K 號：K251114 · 2025-06-20

決定日期2025-06-20

產品代碼DPW

諮詢委員會履歷

決定相當於

器材摘要

FloPatch FP120 is the device name listed in this FDA 510(k) record. The listed applicant is Flosonics Medical. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K251114. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FloPatch FP120?

FloPatch FP120 is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Flosonics Medical. The 510(k) number is K251114.

When did FloPatch FP120 receive FDA 510(k) clearance?

FloPatch FP120 received FDA 510(k) clearance on 2025-06-20, under 510(k) number K251114.

Who is the listed applicant for FloPatch FP120?

The FDA 510(k) record lists Flosonics Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FloPatch FP120?

The FDA product code for FloPatch FP120 is DPW.

其他以 Flosonics Medical 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252810FloPatch FP120 K223843FloPatch FP120 K222242FloPatch FP120

相關器械（代碼：DPW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260700藍多普血管專家BlueDop Medical, Ltd.K252810FloPatch FP120Flosonics Medical K251904VascuChek 套件、VascuChek 轨射器、VascuChek 醫學探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-CP-01、VC-SD-01）；VascuChek 套件、VascuChek 轨射器、VascuChek 外科探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-SP-01、VC-SD-01）Remington Medical, Inc.K243852Elfor-LElfi-Tech , Ltd.K241583VascuChek 套件、VascuChek 訊號傳送器、VascuChek 醫學探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-CP-01、VC-CH-01）；VascuChek 套件、VascuChek 訊號傳送器、VascuChek 外科探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-SP-01、VC-CH-01）Remington Medical, Inc.K223843FloPatch FP120Flosonics Medical

官方來源

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